Introduction: Why E&L Testing Cost Matters More Than Ever in 2025
In 2025, the E&L Testing Cost is a crucial consideration for pharmaceutical companies, biotech startups, and medical device manufacturers navigating evolving global regulations. Extractables and Leachables (E&L) Testing is not just a compliance requirement—it’s a vital step in safeguarding patient safety and product integrity. Understanding how much E&L testing costs in 2025 involves more than quoting a flat fee. It’s about grasping the depth of analytical work, study design, materials used, and regulatory expectations.
At ResolveMass Laboratories Inc., we offer specialized Extractables and Leachables Testing Services supported by industry-leading instrumentation and scientific consultation. Our services are tailored to meet the unique demands of drug-device combination products, packaging materials, and polymeric systems.
See our full E&L testing services here – Choosing the Right E&L Testing Service Provider
What Influences E&L Testing Cost in 2025?
1. Product Complexity & Material Composition
The E&L Testing Cost in 2025 is heavily influenced by the complexity of the product being tested. For example, a single-layer IV bag will be less expensive to evaluate than a combination inhaler with multiple components and interfaces.
The following factors impact your cost:
- Number and diversity of materials (rubbers, plastics, metals)
- Chemical reactivity and potential for extractable compounds
- Novel materials needing customized protocols
Want a custom E&L plan? Learn more here – Customized E&L Testing Solutions for Your Industry
2. Scope of the Analytical Study
An in-depth E&L testing cost also accounts for:
- The number of extraction solvents and conditions
- Study duration (e.g., accelerated vs. real-time)
- Type of simulation (e.g., exhaustive vs. simulated use)
- Testing for volatile, semi-volatile, and non-volatile compounds
Standard studies utilize a combination of GC-MS, LC-MS/MS, ICP-MS, and Headspace Analysis, depending on the regulatory requirements and compound types expected.
3. Regulatory Submissions (FDA, EMA, Health Canada)
The level of E&L testing required differs by regulatory body:
- FDA expects compliance with USP <1663> and <1664>
- EMA requires risk-based analysis and clear justification of extractables
- Health Canada follows ICH Q3E guidelines and demands complete extractable profiles
Compliance with these agencies affects both study design and E&L testing cost, particularly in documentation, validation, and toxicological risk assessments.
Explore our Extractables and Leachables Testing Service Page for our regulatory-compliant testing workflows.
4. Inclusion of Toxicological Risk Assessment
A significant portion of the E&L testing cost in 2025 can come from toxicological evaluation. Once extractables are identified, each compound needs to be:
- Quantified against safety thresholds (e.g., PDE or TTC)
- Evaluated for mutagenicity, carcinogenicity, and cumulative exposure
We offer in-house toxicology expertise, reducing the need for third-party consultants and streamlining your project timeline and cost.
Read how E&L affects patient safety – The Role of E&L Testing in Ensuring Patient Safety
E&L Testing Cost Range in 2025
Here’s a general breakdown of current market pricing:
| Study Type | Estimated E&L Testing Cost (USD) |
|---|---|
| Basic Single Material E&L | $5,000 – $15,000 |
| Complex Multi-Material Device | $10,000 – $25,000 |
| Full Extractable + Leachable + Tox Evaluation | $10,000 – $30,000+ |
Every quote from ResolveMass Laboratories is customized based on scope, timeline, and regulatory filing requirements. Begin your project via our Contact Page.
How to Get an Accurate E&L Testing Quote
When requesting a quote, provide:
- Material composition and drawings of the product
- Intended market (FDA, EMA, etc.)
- Use-case conditions (e.g., injectable, inhaled, topical)
- Regulatory deadline or launch timeline
Got questions? See our full FAQ here – Top Questions About E&L Testing Answered
Reducing E&L Testing Cost Without Sacrificing Quality
Cost-conscious pharmaceutical and medical device companies can reduce expenses by:
1. Bundling Components into One Study
Combine similar materials/components in a single extraction profile.
2. Starting with Risk-Based Screening
We offer tiered study designs, where initial screens focus only on high-risk components.
3. Choosing an Integrated Testing Lab
By working with ResolveMass—where chemistry, method development, and toxicology are all in-house—you eliminate the overhead of multiple vendors.
Learn more on our full Extractables and Leachables Service Page.
Why Choose ResolveMass for E&L Testing in 2025?
ResolveMass Laboratories Inc. is trusted by innovators across North America for our:
- GLP-compliant, ISO 17025-accredited testing facility
- Proprietary method development workflows
- Deep experience in polymer analysis and degradation profiling
- Speed and transparency in reporting and regulatory alignment
Our team brings decades of combined experience in analytical chemistry, regulatory affairs, and quality assurance—making us a partner, not just a service provider.
See how we solved real client challenges – Case Study: Enhancing Product Safety Through Comprehensive E&L Testing
Read what sets our E&L Testing apart and how we support drug-device innovation from R&D to post-market surveillance.
Conclusion: Invest Wisely in E&L Testing Cost in 2025
If you’re searching how much does Extractables and Leachables (E&L) testing cost in 2025, know this: while the E&L testing cost may seem substantial upfront, it’s an investment in regulatory success, patient safety, and long-term cost avoidance. At ResolveMass Laboratories Inc., we deliver precision, speed, and scientific clarity—making your E&L study not just a checkbox, but a strategic advantage.
Learn how leachables impact medical devices – Leachables in Medical Devices
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ResolveMass Laboratories Inc.: Comprehensive Scientific Expertise You Can Rely On
ResolveMass Laboratories Inc. is a trusted Canadian contract research organization offering a wide spectrum of specialized services spanning polymer synthesis, advanced analytical testing, and custom organic synthesis. With over a decade of experience supporting pharmaceutical, biotech, and industrial clients, we bring scientific precision and regulatory insight to every project. Our core capabilities include Polymer Synthesis and Characterization, Peptide Characterization, Organic Synthesis, Nitrosamine Testing and Analysis, PFAS Testing, and Extractable & Leachable Studies, as well as a broad suite of analytical techniques such as HPLC, GC-MS, MALDI-TOF, NMR, and FTIR.
Our multidisciplinary team includes chemists, analytical scientists, and regulatory experts with advanced academic and industry backgrounds. We excel at developing customized, high-quality solutions—whether you need innovative polymer designs, impurity profiling, or confirmatory testing that meets global regulatory standards.
Clients across North America choose ResolveMass Laboratories for our deep technical knowledge, commitment to quality, and ability to deliver reproducible, reliable data that drives confident decision-making. When precision, innovation, and trust matter—ResolveMass is your partner of choice.
We have PhD level scientist who share this knowledge to you so that you can excel in your impurity identification project. This guide will help you understand all the relevant technical aspects, still if you need more help to understand more in your impurity identification, feel free to book a free consultation with our scientist for your project.
REFERENCES
- Thomas F. Understanding Evolving E&L Regulations. In the Lab eNewsletter. 2020 Jan 8;15(1).
- Vas G, Fleck L, Comstock K, Cole J. Extractable and leachable testing for pharmaceutical packaging, finished pharmaceutical products, and medical devices: an analytical perspective.
- Ramamoorthy S, Chong NS, Hotha KK. Strengthening Extractable & Leachable Study Submissions: Best Practices to Avoid Regulatory Deficiencies. American Journal of Analytical Chemistry. 2024 Dec 5;15(12):368-94.
